Comments on: House Committee Passes PDUFA Bill

By: Friday Blog Roundup « The Pump Handle

Friday Blog Roundup « The Pump Handle — Fri, 22 Jun 2007 20:13:00 +0000

[...] Ed Silverman at Pharmalot gives a rundown on the House Energy and Commerce Committeeâ€™s markup of the PDUFA bill on drug review and safety, while Merrill Goozner at GoozNews laments whatâ€™s missing from it. (In other FDA news, The Olive Ridley Crawl gives the agency 1.5 cheers for its final rule on dietary supplements.) [...]

By: Hank

Hank — Fri, 22 Jun 2007 19:15:29 +0000

Thanks for update, Ed. The House additions are useful, but I was disappointed that one sentence that had been proposed was deleted. This would have been an explicit statement that the FDA bill would not constitute grounds for preempting state law (which primarily means civil liability).

The exclusion of this sentence - which only affirmed the status quo of having both FDA regulation and civil liability - constitutes a big victory for the FDA preemption folks. All preemption arguments are based on an interpretation of Congressional intent. This was an opportunity for Congress to state its intent. They didn’t.

By: Prescription Access Litigation

Prescription Access Litigation — Fri, 22 Jun 2007 13:58:58 +0000

The subcommittee that made many of these changes also made another important, and negative change — it removed a provision that would have clarified that the FDA’s approval of a drug does NOT automatically preempt state law court cases alleging that a drug injured people or that a drug company failed to warn patients about known risks. The FDA has been arguing for several years that its authority preempts just about any state law claim, which contradicts years of prior policy, core principles of preemption and common sense.

We at PAL covered this on our blog at http://prescriptionaccess.org/blog/?p=32 and http://prescriptionaccess.org/blog/?p=31